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An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies (NEON-1)

A

Alpine Immune Sciences

Status and phase

Terminated
Phase 1

Conditions

Advanced Solid Tumor
Lymphoma

Treatments

Drug: ALPN-202

Study type

Interventional

Funder types

Industry

Identifiers

NCT04186637
AIS-B01

Details and patient eligibility

About

This is a cohort-based, open-label dose escalation and expansion study in adults with advanced solid tumors or lymphoma, refractory or resistant to standard therapy, or without available standard or curative therapy.

Enrollment

62 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  1. Adult 18 to 75 years old at screening

  2. Pathologically-confirmed, locally advanced or metastatic unresectable solid tumor of an acceptable histology

    Part A (Dose Escalation)

    1. that is refractory or resistant to standard therapy, including checkpoint inhibitor(s) if approved
    2. or for which standard or curative therapy is not available

    Part B (Dose Expansion)

    1. metastatic cutaneous melanoma
    2. PD-L1-positive cancers (other than cutaneous melanoma or renal cell carcinoma)
    3. metastatic renal cell carcinoma
  3. Protocol-defined measurable disease

  4. Available tumor biopsy representative of current disease

  5. ECOG performance status grade 0-2

  6. Life expectancy of ≥ 3 months

  7. Recovery to ≤ Grade 1 for any non-laboratory toxicity resulting from previous anticancer therapy prior to first dose of ALPN-202 (except alopecia, hearing loss, ≤ Grade 2 neuropathy or endocrinopathy managed with replacement therapy)

  8. Adequate baseline hematologic, renal, and hepatic function

Key Exclusion Criteria:

  1. History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation

  2. Active or prior pneumonitis or interstitial lung disease

  3. Presence of any active central nervous system metastases

  4. Prior organ allograft or allogeneic hematopoietic stem cell transplantation

  5. Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.

  6. Receipt of any protocol-restricted therapy within the timeframes indicated:

    1. PD-L1 inhibitors: 5 half-lives (e.g., atezolizumab, 135 days; avelumab, 31 days; durvalumab, 85 days)
    2. Chemotherapy, small molecule anticancer agents (e.g., kinase inhibitors), or radiation: 2 weeks
    3. Other monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, antibody like drugs, cytokines, cell therapies, or radioimmunoconjugates: 4 weeks
  7. Any active, known, or suspected autoimmune disease

  8. Systemic treatment with corticosteroids (> 10 mg/day prednisone) or other immunosuppressive medication

  9. Any second malignancy active within the previous 3 years

  10. Active infection requiring therapy at the time of the first dose of ALPN-202.

  11. Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C.

  12. Known allergies, hypersensitivity, or intolerance to ALPN-202 or excipients in the drug product formulation.

  13. History of Grade 4 infusion-related, anaphylactic or allergic reaction to any previous Fc-based protein therapy.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

62 participants in 1 patient group

Dose escalation and expansion
Experimental group
Description:
ALPN-202
Treatment:
Drug: ALPN-202

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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